Naked Sundays Antioxidant Body Sunscreen Crème Spf 50 Broad Spectrum

Naked Sundays Antioxidant Body Sunscreen Crème Spf 50 Broad Spectrum
SPL v7
SPL
SPL Set ID eb7a84a8-3e25-9988-e053-2a95a90a58a9
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octisalate (5 g) Octocrylene (3 g) Avobenzone
Inactive Ingredients
Alpha-tocopherol Acetate Dimethicone Potassium Cetyl Phosphate Glyceryl Monostearate Phenoxyethanol Ethylhexylglycerin Sodium Benzoate Kakadu Plum Gluconolactone Sodium Polyacrylate (8000 Mw) Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01

Description

AVOBENZONE 3 % HOMOSALATE 10% OCTISALATE 5 % OCTOCRYLENE 10%

Purpose

SUNSCREEN

Dosage and Administration

For External use Only, Apply over skin


Medication Information

Purpose

SUNSCREEN

Dosage and Administration

For External use Only, Apply over skin

Description

AVOBENZONE 3 % HOMOSALATE 10% OCTISALATE 5 % OCTOCRYLENE 10%

Use

- Helps prevents sunburn

- If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

Label

Section 50565-1

If product is swallowed , get medical help or contact a poison control center right away

Section 50567-7

keep out of eyes, Rinse with water to remove

Section 60561-8

Protect the product in this container from excessive heat & direct sun

Warnings

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin.

Skin Cancer/Skin Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent

sunburn, not skin cancer or early skin aging

Directions

Apply generously 15 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours.

Children under 6 months of age: Ask a doctor.

Active Ingredients

AVOBENZONE 3 %

HOMOSALATE 10%

OCTISALATE 5 %

OCTOCRYLENE 10%

Inactive Ingredients

Inactive Ingredients:

Dimethicone, Ethylhexylglycerin, Fragrance, Gluconolactone,

Glyceryl Monostearate, Kakadu Plum, Phenoxyethanol,

Potassium Cetyl Phosphate, Purified Water, Sodium

Benzoate, Sodium Polyacrylate, Tocopherol acetate

Stop Use & Ask Doctor

If rash occurs

Sun Protection Measures :

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad spectrum SPF value of 15 or higher and other sun protection measures inclusing:

- limit time in the sun, especially from 10:00 AM- 02:00 PM

- Wear long- Sleeved shirts , pants, Hats and sunglasses


Structured Label Content

Use (USE)

- Helps prevents sunburn

- If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

Label

Section 50565-1 (50565-1)

If product is swallowed , get medical help or contact a poison control center right away

Section 50567-7 (50567-7)

keep out of eyes, Rinse with water to remove

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat & direct sun

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin.

Skin Cancer/Skin Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent

sunburn, not skin cancer or early skin aging

Directions

Apply generously 15 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours.

Children under 6 months of age: Ask a doctor.

Active Ingredients (ACTIVE INGREDIENTS)

AVOBENZONE 3 %

HOMOSALATE 10%

OCTISALATE 5 %

OCTOCRYLENE 10%

Inactive Ingredients

Inactive Ingredients:

Dimethicone, Ethylhexylglycerin, Fragrance, Gluconolactone,

Glyceryl Monostearate, Kakadu Plum, Phenoxyethanol,

Potassium Cetyl Phosphate, Purified Water, Sodium

Benzoate, Sodium Polyacrylate, Tocopherol acetate

Stop Use & Ask Doctor (Stop use & ask doctor)

If rash occurs

Dosage and Administration

For External use Only, Apply over skin

Sun Protection Measures :

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad spectrum SPF value of 15 or higher and other sun protection measures inclusing:

- limit time in the sun, especially from 10:00 AM- 02:00 PM

- Wear long- Sleeved shirts , pants, Hats and sunglasses


Advanced Ingredient Data


Raw Label Data

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